Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants (In-Motion)

Feasibility of Remote Early At-risk Diagnosis for Cerebral Palsy in High-risk Infant Follow-up Clinics in The Central Norway Regional Health Authority

Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central Norwegian Regional Health Authority (CNRHA).

The most accurate method to detect and predict CP at an early age is the General Movement Assessment (GMA). GMA is based upon expert observations of infant spontaneous movements in a video. In Central-Norway such expertise is today only present at St. Olavs Hospital, Trondheim University Hospital. Video recordings by health personnel and parents will be used in follow-up programs within CNRHA for remote expert based GMA. In addition, machine learning models will be applied for automatic detection of CP.

Early identification of CP will lead to improved function and increased possibility to direct health care resources to the patients who need it most, independent of geographical and expert based constraints.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Lars Adde, phd; Phone Number: +47 91897615; Email: lars.adde@ntnu.no
• Study Contact Backup: Name: Ragnhild Støen

Study Locations

• Norway
  • Levanger, Norway
    • Recruiting
    • Department of Pediatrics, Nord-Trøndelag Hospital Trust
    • Contact: Kristin Bjornstad Aberg, md; Email: kristin.bjornstad.aberg@hnt.no
  • Trondheim, Norway
    • Recruiting
    • Department of Pediatrics, St. Olav's Hospital Trust
    • Contact: Kristine Hermansen Grünewaldt, md phd; Email: Kristine.Hermansen.Grunewaldt@stolav.no
  • Ålesund, Norway
    • Recruiting
    • Department of Pediatrics, Møre and Romsdal Hospital Trust
    • Contact: Beate Horsberg Eriksen; Email: beate.horsberg.eriksen@helse-mr.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 months (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

High-risk infants referred to high-risk follow-up at discharge from one of the participating Neonatal Intensive Care Units, are candidates for enrollment. Following review of the inclusion and exclusion criteria, eligible subjects will be invited to participate. All subjects (parents) must give written informed consent prior to any study procedures being carried out.

Description

Inclusion Criteria:

• hospitalized at a Neonatal Intensive Care Unit (NICU) within the Central Norway Regional Health Authority that is referred to follow-up in the Specialist Health Services containing a team of minimum a pediatrician and a physiotherapist.
• at high-risk for adverse neurological outcomes as considered by the pediatrician on the basis of clinical judgement (example: serious asphyxia, prematurity, stroke, brain hemorrhage)

Exclusion Criteria:

• Peripheral neuromotor disease e.g. brachial plexus injury
• iatrogenic restricted movements (e.g. cast for clubfoot)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Scorable video for remote GMA	1 week
Correlation of computer software data between standard video set-up and handheld smartphone video.	1 week
Predictability of GMA and computer-based assessment for development of CP	2 years
Predictability of GMA and computer-based assessment for development of CP	5 years

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Helse Nord-Trøndelag HF; Alesund Hospital
• Investigators: Study Director: Lise Støylen, St Olavs Hospital, Clinic of Clinical Services; Study Director: Torstein Rø IKOM, Norwegian University of Science and Technology, IKOM

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Diagnosis; Movement; Infants; Smartphone app; Movement disorders; Videos
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: REK 62240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No